Condition category
Ear, Nose and Throat
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W J Fokkens

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Otorhinolaryngology
Room A2-234
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3789
W.J.Fokkens@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR719

Study information

Scientific title

Acronym

ViMiNa

Study hypothesis

Xylometazoline nasal spray relieves vasoconstriction in the nasal mucosa, which will be assessed and visualised using sidestream dark-field (SDF) imaging.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nasal disorder

Intervention

The microcirculation of the nasal mucosa of healthy controls will be assessed using a non-invasive probe, diameter 0.5 cm, which will be placed in the nasal cavity, twice for a period of approximately 10 minutes. Images will be recorded to make off-line analysis possible. In between the two periods of recording or measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes, a second measurement will be taken to assess possible differences in the microcirculation.

Intervention type

Drug

Phase

Not Specified

Drug names

Xylometazoline

Primary outcome measures

The following parameters will be used to assess the microcirculatory reaction after provocation:
Flow in the capillary, venules and arterioles can be scored semi-quantitatively or quantitatively:
1. Semi-quantitative scoring:
0 = no flow
1 = intermittent flow
2 = sluggish flow
3 = continuous flow
2. Quantitative scoring: velocity, flow, diameter, length, density

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2006

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps
2. Males or females aged over 18 years; no maximum age
3. Approval from the patient's physician
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Smoker
2. Severe cardiac or pulmonary disorder
3. Peripheral vascular disease
4. Medication: systemic alpha-blockers, corticosteroids (local and systemic), any local nasal treatment, bronchodilatory inhalation medication for pulmonary diseases >1000 µg/day
5. Cystic fibrosis, immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis
6. Cocaine and/or alcohol abuse

Recruitment start date

01/07/2006

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Otorhinolaryngology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes